- Daiichi Sankyo, Inc. (Bernards, NJ)
- …direction to Biostats Data Mgmt & Data Ops for EDC, edit checks, data quality listings, SAP, Data Mgmt plan; Reviews patient population and protocol compliance for ... Reviews emerging clinical data regularly; Leads dose-escalation meetings; Performs quality assessment with Delivery Lead eg review Tables/Listings/Graphs before… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …other research areas centered around rare diseases and immune disorders. Summary The Associate Director of Regulatory Writing is a key role responsible for producing ... scientifically accurate, high- quality clinical regulatory documents while adhering to regulatory guidelines....and strategic insights at the study team level. The Associate Director of Regulatory Writing must possess advanced knowledge… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …relevant advancements to optimize system performance and functionality. - Data Quality , Testing and Release ManagementEstablish and enforce robust data governance ... test, audit and validate HR data to maintain high data quality standards.Conduct system audits, optimize performance, and troubleshoot technical issues.Develop… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Global Labeling Operations and Compliance Leads to produce high quality labeling documentation.Establishes Processes and Best Practices: Reinforces labeling best ... practices at cross-functional meetings. Assists in the development of Standard Operating Procedures (SOPs) and process improvements. Follows agreements with external partners.Department Coordination: Builds cross-functional and cross-regional… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …capture and reporting. Establishes EDC standards for reporting to ensure quality and compliance in safety reporting.Qualifications: Successful candidates will be ... able to meet the qualifications below with or without a reasonable accommodation. Education Qualifications (from an accredited college or university)Bachelor's Degree Science degree requiredMaster's Degree preferred orPharmD preferred orRN degree preferred… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …of statistical activities; collaborates closely with data manager to ensure high quality data.Drug Development Strategy: Provides input to multiple aspects of the ... development plan to ensure the study designs at each phase of the development are scientifically sound, can fulfill regulatory requirements and deliver the pre-specified product profile.CRO / Vendor Oversight: Review CRO/vendor proposal and budget. Establishes… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …smooth transition with other sub projects with respect to supply, product quality and stakeholder satisfactions. Responsible to communicate and escalate to Senior ... CMC Lead regarding the activity status and potential critical issues, or to the governance bodies. Responsibilities - Accountability to lead teams within overall CMC development project(s), to support Sr CMC Lead. In case no Sr CMC Lead is established, take… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …meet aggressive deadlines to ensure that regulatory agencies receive timely and quality submissions, shortening the review process and leading to successful approval ... of pharmaceutical applications for the company's growth, thereby accomplishing corporate goals.ResponsibilitiesDevelop and implement US regulatory strategy for assigned project(s).Strategize and plan for FDA meetings for assigned product. Liaise, negotiate and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …of statistical activities; collaborates closely with data manager to ensure high quality data.- Drug Development Strategy: Provides input to multiple aspects of the ... development plan to ensure the study designs at each phase of the development are scientifically sound, can fulfill regulatory requirements and deliver the pre-specified product profile.- CRO / Vendor Oversight: Review CRO/vendor proposal and budget.… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Pharmacology, Clinical Safety and Pharmacovigilance, Regulatory/Risk Management, Quality Assurance, Medical Affairs, Translational Research, Research, Informatics ... Services, Project Management and Operational Management. The Tech Lead must have the ability to develop a strong, positive strategic business partnership with the global business and Global IT functions at Daiichi Sankyo. As a trusted partner, provide… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …supporting documents and evidenceSupport with implementing and ensuring global DBMA quality standards for Change requests IT Vendor Oversight and ManagementManaging ... all data requests, perform self-QC of data to ensure quality of results. Service Provider Oversight & ManagementOversight of...usual.Leads or assists in the tracking and investigation of quality and compliance issues OtherReview and update of DMA… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …responsibilities. Leads complex supplier negotiations and commercial contracts for quality and value creation. Enhances the procurement capability by helping ... to develop and deliver processes, training, procurement technology and knowledge management tools. Closely partners with senior Business stakeholders to design optimal processes and sourcing solutions that meet the business' objectives and produce synergies… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …teams, clinical safety and pharmacovigilance, CROs, and partners to ensure high quality coding deliverables are on time to support drug development processes and ... and Strategy:Responsible for medical coding deliverables for assigned programs meeting quality and time expectations for both in-house and outsourced studies.… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …immunotherapy in the treatment of multiple myeloma.Legend Biotech is seeking QA Batch Disposition Associate Manager as part of the Quality team based in Raritan, ... of drug products for human use. This position is responsible for quality and maintaining the highest standards in compliance within company policies, procedures,… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionPosition Description:Reporting to a Technology Director or Associate Director in Global Engineering Solutions (GES), the Associate Director will ... portfolio of Large Molecule, Small Molecule, and Animal Health work.The Associate Director participates in project activities ranging from business case development… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionWe are seeking a detail-oriented Associate Director of Consolidation Accounting, tasked with the role of overseeing the accurate and timely ... analytical and computer skillsAbility to work under pressure to deliver high- quality results for specific deadlinesAbility to work well independently, as well… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionJob Overview:-We are seeking a highly qualified and experienced Associate Director in Data Management to lead our data management team in supporting ... with numerous stakeholders such as , Clinical Research Associates, Statisticians, Quality Assurance, and Regulatory Affairs to drive data excellence and enhance… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionPosition Description: Associate Principal Statistical Programmer - Oncology (Hybrid) In BARDS (Biostatistics and Research Decision Sciences), a ... benefit of patients and global human health.This position provides high quality statistical programming analysis and reporting deliverables for global stakeholders.… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionThe Associate Director Data Science will be responsible for developing and communicating data-driven and actionable insights that drive greater ... strategiesBe accountable for ensuring delivery of analyses with high quality standards, timeliness, compliance, and excellent user experience (routinely keep… more
- Merck & Co. (Rahway, NJ)
- …Clinical Supply Planning program representative) such as clinical development, regulatory, quality and other supply chain areas to negotiate timelines,- strategies ... software . - Familiarity with Good Manufacturing Practices (requirements, quality procedures, and Standard Operating Procedure execution. - - GCSCareer25… more
